Sanofi

Global pharma company; vaccines and R&D

Pharmacovigilance Quality & Compliance Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeTokyo, JapanNo salary listedIn-person

About the Job

Requirements

Ability to create and implement appropriate safety processes from a quality and compliance standpoint.
Solid knowledge of audit and inspection, and experience with Japan GVP.
Commitment and ethical standards to fulfill responsibilities in maintaining compliance with global and local pharmacovigilance regulatory obligations.

Responsibilities

Ensure processes that comply with local pharmacovigilance regulations and global procedures are implemented, documented, and followed locally, including quality document management and self-inspection.
Create and revise Safety Data Exchange Agreements, pharmacovigilance contracts for safety information exchange, and GVP or non-GVP agreements; advise on global pharmacovigilance contracts for Japan's pharmacovigilance business.
Manage document storage, including document transfer when approval is transferred, and serve as the document-management contact in Japan pharmacovigilance.
Control audits and inspections and prepare for them; coordinate GVP inspections and GxP audits.
Lead Quality in Japan PSPV through self-inspection, change management, and deviation management and corrective and preventive action implementation; understand global quality processes and implement them in Japan in consideration of local regulations.
Serve as the Japan organization's contact for training on general topics and local safety regulations; communicate with the global training leader and implement training in Japan; lead Japan's GVP training program.

Job title: Pharmacovigilance Quality & Compliance Manager

Location: Tokyo
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Job role
Fulfill responsibility that processes to comply with local PV regulations and the global procedures are implemented, documented and followed locally (QD management, self-inspection, etc.)
Fulfill responsibility on creation and revision of SDEA, PV contract for safety information exchange and/or GVP and non-GVP agreement. Serves as a consultant/advisor GPV contracts serving Japan PV business.
Fulfil responsibility on storage including document transfer at a transfer of approval. Window person of document management in Japan PV.
Take control Audit and Inspection and its preparation. Coordination of GVP inspection and GxP Audit. Hard knowledge and experience about Audit/Inspection.
Fulfill responsibility to lead Quality in J-PSPV by conducting “self-inspection”, “Change Management, and “Deviation Management /CAPA implementation” .Understand the Global Quality process and implement it to Japan considering local regulation.
Within Japan organization, to be a window person of training about general topic and local regulation for safety mutters. Keep communication to global training leader and implement to Japan. Leader of Japan GVP training program.

Personal requirements

Ability to create and implement appropriate safety processes from quality and compliance standpoint.
High level of coordination, communication and negotiation skills.
Solid knowledge of audit/inspection, experience with Japan GVP.
Commitment and ethical standard to fulfill responsibility in keeping SaKK in compliance with both global and local PV regulatory obligations

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About the Company

Sanofi

Global pharma company; vaccines and R&D

Sanofi is a global pharmaceutical and biotechnology company that develops, manufactures, and sells prescription medicines, over-the-counter products, and vaccines. Its products span immunology, oncology, rare diseases, and vaccines, addressing unmet medical needs through a strong focus on research and development. Sanofi's core product model relies on large-scale R&D, strategic partnerships, and licensing to bring new therapies to markets, with revenue generated from product sales and collaborations. The company differentiates itself by leveraging its global reach, diverse portfolio, and emphasis on patient-centric solutions, safety, and quality to navigate regulatory environments in developed and emerging markets. The company’s goal is to improve health outcomes and quality of life for people worldwide by delivering innovative treatments and vaccines that meet unmet medical needs.

Company size: 10,001+
Company stage: IPO
Headquarters: Paris, France
Founded: 1973

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